A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia

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Title: A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia
Author(s): Duffy, JMN
Hirsch, M
Gale, CRK
Pealing, L
Kawsar, A
Showell, M
Williamson, PR
Khan, KS
Zeibland, S
McManus, RJ
Item Type: Journal Article
Abstract: Background An evaluation of outcome reporting is required to develop a core outcome set. Objectives To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Search strategy Five online databases were searched from inception to January 2016 using terms including “preeclampsia” and “randomized controlled trial”. Selection criteria Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Data collection and analysis Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Main results Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. Conclusions In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.
Publication Date: 7-Sep-2017
Date of Acceptance: 13-Aug-2017
URI: http://hdl.handle.net/10044/1/50425
DOI: https://dx.doi.org/10.1002/ijgo.12298
ISSN: 0020-7292
Publisher: Wiley
Start Page: 262
End Page: 267
Journal / Book Title: International Journal of Gynecology and Obstetrics
Volume: 139
Issue: 3
Sponsor/Funder: Medical Research Council
Funder's Grant Number: MR/N008405/1
Copyright Statement: This is the peer reviewed version of the following article: Duffy, J. M.N., Hirsch, M., Gale, C., Pealing, L., Kawsar, A., Showell, M., Williamson, P. R., Khan, K. S., Ziebland, S., McManus, R. J. and the International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE) (2017), A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia. Int J Gynecol Obstet. doi:10.1002/ijgo.12298, which has been published in final form at https://dx.doi.org/10.1002/ijgo.12298. This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.
Keywords: Core outcome sets
Maternal
Newborn
Outcome reporting bias
Pre-eclampsia
Randomized controlled trials
Systematic review
International Collaboration to Harmonize Outcomes for Pre-eclampsia (iHOPE)
1114 Paediatrics And Reproductive Medicine
Obstetrics & Reproductive Medicine
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine



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